Randomized Controlled Trial to Compare Two Anti-scorpion Serums

Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

Status and phase: Completed; Phase 4

Conditions: Scorpion Sting

Treatments: Biological: serum antiscorpion

Study type: Interventional

Funder types: Other

Identifiers

NCT00739440

Birmex-01-2008

Details and patient eligibility

About

The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum

Full description

We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum.

Enrollment: 120 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sting scorpion
• Informed consent
• Age 15-60
• Either sex
• Resident in study area

Exclusion criteria

• Previous treatment with gammaglobulin
• Blood transfusion at any stage of life
• Sensitivity or intolerance to serums antiscorpion or horse products
• Pregnancy
• Some immunodeficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

I

Experimental group

Description:

Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex

Treatment:

Biological: serum antiscorpion

II

Experimental group

Description:

Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)

Treatment:

Biological: serum antiscorpion